A randomised trial to evaluate improved routine communication to patients and carers after stroke

ISRCTN	ISRCTN41666882
DOI	https://doi.org/10.1186/ISRCTN41666882
Protocol serial number	RCRC9C YOUNG R&D
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive Northern and Yorkshire (UK)

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 02/10/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof John Young
Scientific

Bradford Hospitals NHS Trust
St Luke's Hospital
Little Horton Lane
Bradford
BD5 0NA
United Kingdom

Phone	+44 (0)1274 365 311

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	The provision of clear information following a stroke has been identified as a key component of good care by both health professionals and patients. The provision to the patient and family of understandable, appropriate and correct information may be effective in positively influencing post-stroke home care. However, a number of recent reports have demonstrated that the implementation of this policy into routine practice may be difficult to achieve. Several small studies in the UK have highlighted the difficulties in successfully implementing strategies for information provision. No evidence of effectiveness in reducing anxiety or improving social functioning has been reported but there was a suggestion that the patients were more satisfied with their level of knowledge and appreciated booklets. It is likely that the method of delivering the information is as important as its content. Simply providing information, particularly when set in a complex area such as stroke, may be too simplistic as it is too passive an approach. A more active, educational approach may be successful. Thus a formal educational or teaching programme specifically designed for patients and carers may have some special relevance. Such an experimental educational programme was established and evaluated in the USA and reported positive effects including improving caregiver stroke knowledge and family coping strategies. To develop this work further we are going to evaluate by randomised trial the effectiveness of a short educational programme for patients and caregivers after stroke. Research Questions 1. That a structured package of information provision for patients recovering from stroke and their carers is associated with improved to usual (unstructured) information provision. 2. That a structured package delivered by a facilitator is more effective than either simple provision of the structured information, or usual care. The primary outcome of interest is patient and carer understanding of stroke, with a secondary outcome of reduction in handicap.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Cardiovascular diseases: Cerebrovascular disease
Intervention	1. Group 1 Unstructured information provision 2. Group 2 Structured information provision - the Stroke Recovery Programme 3. Group 3 Stroke Recovery Programme delivered by a facilitator
Intervention type	Other
Primary outcome measure(s)	1. Knowledge about Stroke and Service questionnaire 2. London Handicap Scale
Key secondary outcome measure(s)	1. Patients will be asked to complete 1.1. Patients Satisfaction Questionnaire 1.2. Frenchay Activities Index 1.3. Hospital Anxiety and Depression Scale 2. Carers will be asked to complete 2.1. General Health Questionnaire 2.2. Carers Satisfaction Questionnaire An estimate of the resource use will be made by recording the time taken by the three specialist nurses during the one-to-one sessions with patients and carers.
Completion date	12/01/2002

Eligibility

Participant type(s)	Patient
Age group	Other
Sex	Not Specified
Target sample size at registration	220
Key inclusion criteria	The Bradford Stroke Unit receives patients of any age shortly after stroke onset (average 11 days) who are sufficiently medically stable to participate in a rehabilitation programme. On admission patients and their carers (if available) will be screened for recruitment into the trial within three days of transfer. Patients will be eligible for the trial if they have a diagnosis of acute stroke and give informed consent. Thus we will be recruiting a heterogeneous study sample of patients (n=220) with various stroke impairments and differing ethnic backgrounds. For patients with server aphasia or stroke related cognitive impairment the main emphasis of the information provision will be directed toward the main carer.
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	11/01/1999
Date of final enrolment	12/01/2002

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Bradford Hospitals NHS Trust

Bradford
BD5 0NA
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2004		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes